Teratogenic Medicines Advisory group minutes: October 2024

Attendees and apologies

• Alison Strath (Chair), Chief Pharmaceutical Officer (CPO), Scottish Government
• Marion Bennie, Chief Pharmacist, Public Health Scotland
• Leanne Hopkins, Principal Information Analyst, Public Health Scotland
• Lynne Jarvis, Principal Information Analyst, Public Health Scotland
• Scott Brown, Pharmacy Clinical Leadership Fellow, Public Health Scotland
• Rory Chapman, Health and Social Care Alliance Scotland  
• Craig Heath, Consultant Neurologist and Honorary Senior Clinical Lecturer, NHS Greater Glasgow and Clyde
• Alpana Mair, Head of Effective Prescribing and Therapeutics team, Scottish Government
• Iain Wilson, Clinical Lead (GP), Effective Prescribing and Therapeutics, Scottish Government
• Stuart Law, Effective Prescribing and Therapeutics team, Scottish Government
• Roch Cantwell, Consultant Perinatal Psychiatrist, Perinatal Mental Health Network Scotland
• Alistair Cook, Principal Medical Officer, Scottish Government
• Hannah Porter, Pharmacy Clinical Leadership Fellow, NHS Lothian
• Dionne Mackison, Head of Medicines Policy, Scottish Government 
• Frauke Hunter, Medicines Policy Team leader, Scottish Government
• Gemma McCormack, Senior Policy Manager, Scottish Government 

Apologies                    

• Scott Hill, National Clinical Lead, Healthcare Improvement Scotland
• Justine Craig, Chief Midwifery Officer, Scottish Government
• Richard Davenport, Consultant Neurologist, NHS Lothian
• Laura Byrne, Director of Pharmacy, NHS Forth Valley
• Andrew Walker, Lead Clinical Pharmacist Adult Mental Health, NHS Greater Glasgow and Clyde         
• Corinne Love, Senior Medical Officer, Maternity and Women’s Health, Scottish Government

Items and actions

Welcome and introductions

The Chair welcomed everyone to the Scottish Government Teratogenic Medicines Advisory Group (TMAG) meeting and invited members to introduce themselves. The Chair noted apologies. The Chair welcomed the two clinical leadership fellows to the meeting and invited them to participate fully in the discussions.

Minutes and actions from meeting of 25/06/2024

The minutes of the last TMAG meeting were agreed as accurate.

Actions are either completed or covered on the agenda, and the following updates were provided:

Scottish Government (SG) Medicines team met with the Effective Prescribing team on 6 August. The Effective Prescribing team suggested asking members of TMAG which medicines should be a  priority for development of indicators.

SG medicines policy team met with Digital colleagues on 31 July to discuss what can be done to capture medicines indication data to improve patient safety, and what timescales were realistic. The importance of accurately capturing data was highlighted. It was noted that indication data is captured in medical records and case notes, but not in prescribing system. Digital colleagues are investigating whether they have resource to undertake business analysis to map out how this will work. This work is ongoing, and the medicines policy team will arrange a follow up meeting.

• action 1: SG medicines policy to arrange follow up meeting with digital colleagues

It was noted the draft position statement on specialist services is under review and will be shared with members electronically for comment.

• action 2: SG medicines policy to circulate draft position statement for comment 

It was noted SG medicines policy team commissioned Public Health Scotland (PHS) via its Medicines in Pregnancy (MiP) asset to monitor Scotland level data, and that at the request of TMAG members, next year Health Board level datas will be made available for management purposes, not as part of the public facing dashboard. It was noted that there are existing, stand alone, local systems for patient data at GP practice level and therefore this would not be part of MiP. The Medicines and Healthcare products Regulatory Agency (MHRA) are of the same view, and they will also consider management data at Integrated Care Board level.

It was noted that a retired Clinical Geneticist from the University of Aberdeen who has done research and has clinical expertise in valproate was identified to present at the Social Security Scotland awareness session through the Royal College of Psychiatrists.

TMAG work plan

The TMAG work plan discussion paper was circulated with the agenda which proposed priorities and next steps in relation to valproate and other medicines with teratogenic potential.

It was noted that some members had issues opening the document, so members talked through the work plan at the meeting.

It was agreed that it would be useful to understand Healthcare Improvement Scotland (HIS)’s view on how successful the  shared learning network is.

• action 3: HIS to provide feedback on the shared learning network at the next meeting i.e. uptake numbers and any specific outputs

Members discussed that in the absence of a MHRA list of teratogenic medicines, a good starting point for identifying future priorities would be to use the MHRA list of medicines with formal Pregnancy Prevention Programme (PPP)’s in place, for example a number of cancer medicines.

Members agreed focusing on all Anti-Seizure Medicines (ASM's) first before considering a different medicine group, such as anti-depressants (which the MHRA had suggested may be the next area they focus on) in the future, subject to data availability. It was noted that with the new MHRA guidance for male patients on valproate, male exposure will be of interest.  

PHS confirmed data on male exposure will be included as part of the next data publication in April 2025. It was noted that PHS cannot link a fathers’ Community Health Index (CHI) number to be able to show a linkage with a pregnancy, whereas there is a process for linking women’s CHI numbers with the baby CHI number.

It was agreed that a separate meeting with the SG Maternal Health team, the Effective Prescribing team and a neurologist would be arranged to consider what may be possible in light of the potential upcoming changes for male patients.

• action 4: SG medicines policy team to arrange a meeting with SG Maternal Health team, neurologist and the Effective Prescribing team

It was noted further comments or amendments to the work plan should be sent electronically to the medicines policy team following the meeting.

• action 5: members to send comments on the workplan to SG medicines policy team before finalising and publishing on the webpage

Update from PHS on the Medicines in Pregnancy surveillance asset

The Chair invited PHS to speak to this item: PHS summarised the purpose, progress update and plans as detailed in the SBAR which was circulated prior to the meeting. PHS also talked through the interactive dashboard which was published on 1 October. 

In response to the declining figures shown on the dashboard, it was noted that it was interesting 41% of women stopped their medication during pregnancy and members discussed whether that could be due to the concerns of taking valproate or if valproate was prescribed for another indication (not epilepsy).

PHS welcomed feedback from members and noted this can be done directly to the PHS mailbox. 

PHS will update SG medicine policy team as sponsors, with what is practical and/or required going forward.

Update on medicines policy work

Medicine policy team provided a summary of policy work since the last meeting:

English Patient Safety Commissioners Hughes Report - policy officials continue to liaise with their counterparts at the UK Government to understand their proposed direction of travel. Following the General Election, another letter was sent to the new UK Minister on 1 October, asking for assurance that the UK Government will consult with the Devolved Governments in a timely manner and share details of any proposals that are under development so that any implications for Scotland can  be considered.

Specialist services recommendation 5 from the First Do No Harm report - the position statement is under review and will be circulated to members for comment.

Social Security Scotland (SSS) Awareness session - SG Medicines policy team are working with social security colleagues to hold a valproate awareness ‘in conversation session’ for social security decision makers and the organisation in general, this will include a short presentation by the health professional with knowledge of the condition, a segment on lived experience, followed by Question and Answers. SG Medicines policy team have now identified a clinician volunteer and someone with lived experience through patients group contacts, their contact details have been passed on to SSS colleagues are waiting for a date for the session to be confirmed.

Update from the Anti–Seizure Medicines (ASM) Task and Finish group

The Chair invited the medicine policy team to speak to this item in the ASM group Chair's absence. 

It was noted the ASM group formed in January 2024 and produced an internal assurance checklist for NHS Boards in Scotland for prescribing valproate, in line with the MHRA regulatory changes.

It was noted that following the PHS publication in April, the group’s focus turned to topiramate prescribing and members agreed to produce an assurance checklist for prescribing topiramate, similar to valproate.

It was noted the ASM group agreed that a consensus statement should be drafted in addition to the checklist, to ensure primary care colleagues are aware of the updated information for prescribing topiramate for migraine prophylaxis. The Chair of the ASM group liaised with HIS to arrange for the consensus statement to be produced through the Area Drug and Therapeutics Committee (ADTC) Collaborative and linking with PHS to help GPs identify patients at risk. This is currently underway. 

It was noted the group has also worked with Learning Disability colleagues to produce easy read versions of the Patient information Leaflet (PiL) and a Decision support tool for valproate, copies of these documents were circulated alongside the agenda prior to the meeting.

It was noted that the ASM group held its final meeting on 21 August.

Members were asked how best to promote access to the easy read tools and to send suggestions to the medicine policy team after the meeting. 

• action 6: Members to send suggestions on the most effective way to promote access to the easy ready tools

Update from the valproate learning network

This item will be carried over to the next meeting.

Any Other Business

The Chair thanked everyone for their contributions to the meeting. There was no other business raised.

The medicines policy team will arrange the next meeting of the TMAG for April 2025.

• action 7: medicine policy team to arrange the next TMAG meeting